The new generation zit zapper

Summary: This DermaFiction story is based on the recent report of an iPhone app that is claimed to be effective in acne. The device is not FDA approved.

The news conference was hastily arranged. Professor Anderson fidgeted in his chair. He appeared to be distinctly uncomfortable with the whole proceedings. Probably he was not ready for this. At least not as yet.

The idea was simple. The idea struck when he saw his 12-year-old son Jeff playing his favorite game on his new iPhone. When the missile hit the alien the screen flashed red and blue lights as the device vibrated in his tender hands. The lights reflected on his face as it lit up with a faint smile.

Prof. Anderson was a pioneer in photodynamic therapy. (1) It is a form of treatment where a photosensitizing chemical is administered and subsequently excited by light of certain wavelengths. He has used the technology for a variety of conditions including acne. He has noticed that acne improves with blue light even without a photosensitizing chemical. (2)

If a mobile phone can emit blue light so close to the face, why can’t it be used for the treatment of acne? He immediately contacted his cousin Bob who was a computer wiz. “Creating an iPhone app emitting blue light is not a big deal”, Bob said. Prof. Anderson gave the specifications to Bob and he fulfilled his promise in few days. Professor decided to give it to his acne patients to try. The same day Bob showed him how to upload it to iTunes.

A phone call woke him up on the next weekend. One of his patients congratulated him for being number one, but he was still half asleep and did not understand what he was talking about. Soon he realized that the app he uploaded to iTunes has been voted as the No.1 medical app. (3)

Prof. Anderson just woke up from his reverie to catch the last part of the journalist’s question. Will it work? That was the question or something similar to that.

“I don’t know”, he said. “But the science is sound. I have not tried it as yet. The intensity of light may be too weak. But I still believe a mobile phone can be used as a light source for photodynamic therapy. It is the next step and I am working on it.”

You mean to say you have not tried it as yet. You actually released a medical device without actually testing it. The lady journalist’s lips quivered as she asked this.

“This is not a medical device. It is just for entertainment.” Professor said, but the journalist was not convinced.

“Don’t you think you owe the public some studies to show its effectiveness?"

“Well, do you ask every mobile game programmer to provide proof that the game is entertaining?”

“But……..” Professor missed the last question. He was looking at Jeff playing with his iPhone again.


References:
1. Riddle CC, Terrell SN, Menser MB, Aires DJ, Schweiger ES. A review of photodynamic therapy (PDT) for the treatment of acne vulgaris. Journal of Drugs in Dermatology: JDD 2009;8(11):1010-1019.
2. Sadick N. A study to determine the effect of combination blue (415 nm) and near-infrared (830 nm) light-emitting diode (LED) therapy for moderate acne vulgaris. In: Journal of Cosmetic and Laser Therapy: Official Publication of the European Society for Laser Dermatology; 2009. p. 125-128.
3. http://www.medicinenet.com/script/main/art.asp?articlekey=113342

Honey, I shrunk the SPF.

Description: Sun Protection Factor (SPF) is a popular marketing concept with little clinical relevance. Sun protection does not mean diligent use of sunscreen. This article belongs to DermaFiction series.


I am not Copernicus to say that sun is the centre of life. I do believe excessive sun exposure has harmful effects and tanning should not be encouraged. I do believe that certain wavelengths within solar spectrum can hasten the ageing process (at least the visible signs of it). But I DO NOT believe that sunscreen is the panacea for all your sun woes. I DO NOT believe that our good old sun (whom Hindus worship as Sun God) is the biggest killer, humanity has ever witnessed.

Finally I have said it! I am sure I am going to pay dearly for those two ‘DO NOT’s. I am sure the mercenaries of the notorious multi-billion dollar sunscreen industry will be lurking in the darkness to silence me forever. I can see one black Mercedes stopping in my driveway.

The magic figure of 100 SPF was the biggest and perhaps the most effective tactic adopted by you-know-who. The poor unsuspecting muggles assumed that 100 imply 100 percent protection. They never understood the magic equation of SPF that translates 50 SPF to 98% and 100 SPF to 99% protection. Then the almighty FDA shrunk all 100 SPF sunscreens to 50+ (1) recognising the limitations in present SPF determination (2). Do I hear footsteps outside?

Melanoma, the serial killer on the prowl is supposed to be sun’s recruit. But the evidence in favour of the use of UV weapon in melanoma's killing spree is not consistent. Majority of melanomas occur in areas not directly exposed to sunlight. Circumstantial evidence suggests gene mutations. In any case our 100-SPF friends failed to control melanoma. The incidence of melanoma continues to rise at a rate faster than that of many common cancers.(3) Non-Melanoma cancers are more associated with UV exposure, but are generally not lethal. The footsteps are near now. They may be here any moment.

During 10 years of my clinical practice in India and Middle East as a dermatologist, I have been seeing one or two sun induced skin disorders every other day but I see just as many sunscreen induced acne and an occasional contact dermatitis from sunscreens. My research showed that SPF is directly proportional to amount of sunscreen applied at least on pigmented skin though cost may follow a geometric progression.(4) Many of us are not aware that an umbrella (5), wide brimmed hat and even clothing (6) can give you sun protection. This is often expressed in terms of Ultraviolet protection factor (UPF) and it comes at no cost and no side effects. Do I hear a knock on my front door?

My hands were trembling when I opened the front door. He just stared, his eyes flashing coldness, having a macabre look inside my soul. “We have our answer to FDA. Hope you have seen that” (7) he said. Only his lips moved. The rest of his body remained still.

“But you need the sun for Vit D...” (8) I could not finish. The silencer muffled the shot. But it found the target. He waited for few minutes till the sunscreen advertisement on the TV finished and walked back to his Mercedes.

References:

1. Sayre RM, Dowdy JC, Lott DL, Marlowe E. Commentary on 'UVB-SPF': the SPF labels of sunscreen products convey more than just UVB protection. Photodermatol Photoimmunol Photomed. 2008 Aug;24(4):218-220.

2. Miura Y, Takiguchi Y, Shirao M, Takata S, Yanagida T, Fukui H, et al. Algorithm for in vitro Sun Protection Factor based on transmission spectrum measurement with concomitant evaluation of photostability. Photochem. Photobiol. 2008 Dec;84(6):1569-1575.

3. Aceituno-Madera P, Buendía-Eisman A, Arias-Santiago S, Serrano-Ortega S. Changes in the incidence of skin cancer between 1978 and 2002. Actas Dermosifiliogr. 2010 Jan;101(1):39-46.

4. Sandra A, Eapen BR, Shenoi SD. Effect of thickness of sunscreen on SPF. British Journal of Dermatology (Suppl). 2000;143(57):24.

5. Utrillas MP, Martínez-Lozano JA, Nuñez M. Ultraviolet Radiation Protection by a Beach Umbrella. Photochem Photobiol [Internet]. 2010 Jan 6 [cited 2010 Feb 9];Available from: http://www.ncbi.nlm.nih.gov/pubmed/20059729

6. Gambichler T, Dissel M, Altmeyer P, Rotterdam S. Evaluation of sun awareness with an emphasis on ultraviolet protection by clothing: A survey of adults in Western Germany. J Eur Acad Dermatol Venereol [Internet]. 2009 Jul 13 [cited 2010 Feb 9];Available from: http://www.ncbi.nlm.nih.gov/pubmed/19627409

7. Russak JE, Chen T, Appa Y, Rigel DS. A comparison of sunburn protection of high-sun protection factor (SPF) sunscreens: SPF 85 sunscreen is significantly more protective than SPF 50. J. Am. Acad. Dermatol. 2010 Feb;62(2):348-349.

8. Osterwalder U, Herzog B. Sun protection factors: world wide confusion. Br. J. Dermatol. 2009 Nov;161 Suppl 3:13-24.

Skin Deep – The new beginning

I started skin deep blog in 2006. I was new to blogging that time. I used to post interesting cases on this blog. Few of my friends joined me and I started an offshoot called the 'hair loss blog'. Over the years skin deep blog has grown significantly in popularity reaching the first 3 in google search for dermatology blogs and on 2010 I started displaying paid ads from adhitz. Recently the blogger platform stopped support for FTP blogs like skin deep. I stopped posting during the migration process. The migration process has now been completed but the url has been changed to http://blog.gulfdoctor.net. I am not sure about the impact of this change on link popularity.

There is no dearth of internet sites offering clinical photographs and related information on dermatological disorders. I recently introduced a new concept called DermaFiction on the gray zone between medicine and fiction. I will explain the concept of DermaFiction in my next post. I used the associatedcontent platform for DermaFiction. To cut the long story short, I am planning to migrate the DermaFiction series of stories from associatedcontent to this blog. If you find the concept interesting, feel free to join skin deep as a contributor. Welcome to the new skin deep blog.

My Other blogs are
1.Hair loss blog: http://hairblog.gulfdoctor.net
2.Bioinformatics blog: http://bioblog.gulfdoctor.net
3.Cosmetology blog: http://beapen.mine.nu:7770/blog (Hosted by my laptop, may not be available all the time.

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Requirements for research in cosmetic dermatology

Research in Cosmetic Dermatology: Reconciling medicine with business: (Part II / IV)

The complete article is available as a printable pdf file from the Munich Personal RePEc Archive (MPRA) below:

http://mpra.ub.uni-muenchen.de/16515/

The term research has a different meaning in cosmeceutical industry. Some big organisations use the term for product or service improvement. Optimization of existing technology for specific needs (not necessarily different indications) is a common practice in cosmeceutical industry. Each organization conducts its on research for optimizing the technology. As this is often conducted without a proper understanding of clinical research paradigms, certain errors of judgment are frequently encountered.

THE NEED TO COMPARE
It is always worthwhile to compare new technologies to already available ones in terms of efficacy and adverse effects. For example several depigmenting agents are known with varying levels of efficacy. When a new and more expensive product combination is introduced, it is important to compare it with individual components used alone to justify the cost of the combination. However the decision of whether to adopt a new technology should not be based entirely on the results of comparison. But the comparison will give clear indications about the likely success and the potential problems during introduction and has substantial marketing value.

THE NEED TO RANDOMIZE
Randomization is given due importance in pharma trials. But many cosmeceutical researchers rely on a 'study group cohort 'rather than random sample. The active ingredient, vehicle or even contaminants in a cosmeceutical can cause an allergic or irritant reaction in a small percentage of users.(8) Manufacturers try to assess the risk during the trial period. If the trials are conducted on the same group always, the group undergoes a natural selection process as those who develop a reaction are unlikely to report for further trials. The results on this 'thick skinned' cohort cannot be reliably extended to the general population.

THE NEED FOR BLINDING
Blinding is another important concept often ignored in cosmeceutical research. Sometimes blinding can be difficult or impossible to implement especially for those trials involving machines. Hence most of the studies are plagued by researcher as well as subject bias. This bias gets confounded several times when the researchers also become part of the study group, a practice common in cosmeceutical research. Individual service providers often comment that they have tried the product or service on themselves and found it to be safe and effective. Having an independent blinded observer who does majority of assessment can significantly reduce the bias. But bias cannot be completely removed from study design in cosmeseutical research and should be kept in mind during final evaluation.

THE NEED FOR OBJECTIVE ASSESSMENT
The assessment is often subjective in cosmeceutical research. The unavoidable biases along with subjective assessment methods make the studies less credible. It is important to make full use of new, objective assessment techniques involving computer assisted image analysis and optical spectroscopy. Computer assisted image analysis is the computational extraction of meaningful information from digital images by pattern recognition and digital geometry.(9) Optical spectroscopy involves study of scattering and reflectance pattern of the skin for an objective assessment of appearance. (10)

THE NEED TO USE MOLECULAR AND CELL BIOLOGY TECHNIQUES
The chance of success for a cosmeceutical is likely to be higher if it has a strong basis in molecular and cell biology. Ingredients developed on the basis of its effect on well characterized molecular targets are more likely to be successful. The new generation growth factors and aquaporin modulators are typical examples.(11) The recent developments like in vitro human skin helps in assessing the efficacy and adverse effects of cosmeceuticals in a more objective and safe way.(12)

THE NEED TO CONSIDER SKIN AND LIFE-STYLE VARIATIONS
The importance of skin type in the choice of cosmeceuticals is well known. Certain lasers are considered not safe on darker skin as the chances of developing adverse effects are more.(13) The environment and life style can also have a significant effect on skin biophysical characteristics. Hence it is important to account for these confounding factors in study designs especially for those cosmeceuticals promoted as suitable for all skin types.


THE NEED FOR LONG TERM FOLLOW-UP
Since cosmeceuticals are not strictly regulated, products are introduced based on studies conducted for a few days or weeks or at most a few months. Since a watchdog like FDA is not present, certain technologies are introduced into the market without enough studies to back the safety claims of manufacturers. Often the user is not even aware of this fact. Permanent dermal fillers are a typical example.(14) It is known that foreign bodies can elicit a tissue reaction after prolonged periods of exposure. Hence short term safety of dermal fillers does not guarantee its long term safety after several injections. Long term follow-up studies are lacking for many dermal filler materials. The same applies to other techniques like laser as well.

Research in Cosmetic Dermatology: Reconciling medicine with business: (Part I / IV)

The complete article is available as a printable pdf file from the Munich Personal RePEc Archive (MPRA) below:
http://mpra.ub.uni-muenchen.de/16515/

Cosmetic dermatology is a unique specialty where clinical medicine has a legitimate but often detested relationship with business. There are people lined up on either side of the hazy line between medicine and business, each group trying to understand the other. True clinical dermatologists consider cosmetic dermatology an imprecise and vague specialty.(1)

A cosmeceutical, is conventionally defined as a cosmetic product claimed to have drug-like properties.(2) The term cosmeceutical is a portmanteau of the words "cosmetic" and "pharmaceutical” and is not recognized by Food and Drug Administration (FDA). A cosmeceutical is not subject to FDA review and approval processes.(3) Medical devices used in cosmetic dermatology range from cautery machines to lasers. Injectable enhancement products like Botox®(4) and dermal fillers are also popular. The Division of General, Restorative and Neurological Devices (DGRND) within FDA regulates most of the medical devices and injectable dermal fillers used by dermatologists.(5) In this article the term “cosmeceutical” is used to represent cosmetic products, injectable products and medical devices (like microdermabrasion and laser machines) used in cosmetic dermatology.

The pharmaceutical research paradigms of target identification, screening, lead optimization and clinical trials from phase I to IV do not directly apply in cosmeceutical research.(6) In pharma the industry decides what is good for the patient where as in cosmetic dermatology the patient decides what is good for him/her. Hence it is not imperative that a significant placebo effect be identified and accounted for even if it arises from a dominant bias. A typical example is Laser Hair Reduction. It is very difficult to conclusively prove that it is more effective than any other hair removal method to justify its cost. But it is a billion dollar industry and is considered a ‘successful technology’ in cosmeceutical arena.(7)

This article is an attempt to reconcile research in cosmetic dermatology with business and market research. First we discuss the basic requirements for clinical research in cosmetic dermatology. Then we move on to the uncertainties faced by decision makers and the mathematical models which may be of help in solving them. Finally we briefly discuss the market research techniques used in cosmeceutical industry.

To be continued..

Notalgia Paresthetica

This patient presented to me with this pigmented itchy patch over the right infra scapular region. He had a neurological disorder with paresthesia extending to right finger tips. There is a report of successful treatment of this condition with Botulinum Toxin Type A. [Arch Dermatol. 2007; 143(8):980-982.]